antibody persistence and booster dose response in subjects who received menactra® three years earlier in study mta26

Conditions: Meningitis; Meningococcemia

Summary: study will evaluate the persistence of antibodies approximately three years after an initial dose of menactra® vaccine in toddlers who participated in study mta26 (nct00643916) and age-matched menactra naive participants. objectives: * to assess the persistence of antibody responses three years after one or two doses of menactra® vaccine in subjects who participated in study mta26. * to describe the antibody responses to a single dose of menactra® vaccine in subjects who had previously received one or two doses of menactra® vaccine and in menactra® vaccine-naïve subjects. * to describe the safety profile of a single dose of menactra® vaccine in subjects.

subjects that received menactra® vaccine in study mta26 (nct00643916) and age-matched menactra naive participants will receive a single dose of menactra® on day 0. they will be evaluated for immunogenicity and safety post-vaccination.

Eligibility criteria:
inclusion criteria : * subjects received one or two doses of menactra® vaccine in study mta26 and provided a blood sample after the last dose received * at 3 to \< 6 years of age and were never vaccinated against meningococcal disease (with either the study vaccine or another vaccine). * informed consent form signed and dated by the parent(s) or another legally acceptable representative. * subject and parent/legal guardian able to attend all scheduled visits and comply with all study procedures. exclusion criteria : * participation in the active (i.e., treatment) portion of another clinical trial investigating a vaccine, drug, medical device, or a medical procedure in the 4 weeks preceding the first study vaccination * planned participation in another clinical trial during the present trial period. * known or suspected congenital or acquired immunodeficiency, immunosuppressive therapy such as anti-cancer chemotherapy or radiation therapy within the preceding 6 months, or long-term systemic corticosteroids therapy. * known or suspected systemic hypersensitivity to any of the vaccine components, or history of a life-threatening reaction to the study vaccine or to a product containing any of the substances present in the study vaccine. * chronic illness at a stage that could interfere with trial conduct or completion, in the opinion of the investigator. * received blood or blood-derived products in the past 3 months. * received any vaccine (other than desensitization therapy for allergies or influenza vaccine within 2 weeks before vaccination) in the 4 weeks preceding the first study vaccination. * planned receipt of any vaccine within the 4 weeks following the study vaccination. * known human immunodeficiency virus (hiv), hepatitis b surface antigen (hbs antigen), or hepatitis c seropositivity. * history of invasive meningococcal infection (confirmed either clinically, serologically, or microbiologically). * thrombocytopenia, coagulation disorder, or anticoagulant use in the 3 weeks preceding inclusion contraindicating intramuscular (im) vaccination. * anticipated to receive oral or injected antibiotic therapy within the 72 hours prior to any of the trial blood draws. * personal or family history of guillain-barré syndrome (gbs). * any condition which, in the opinion of the investigator, would pose a health risk to the subject or interfere with the evaluation of the vaccine.

Keywords: meningitis meningococcemia neisseria meningitidis menactra®